LABELS · d2081b19-6f23-454d-b426-2710d8319f23

TRUQAP

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-06-12
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. ( 1.2 ) 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. 1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.

Full extracted label fields

application numbers

NDA218197

boxed warning exact

brand names

TRUQAP

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d698c106-2322-401e-b738-cbd83c843ecf

generic names

CAPIVASERTIB

d2081b19-6f23-454d-b426-2710d8319f23

indications and usage exact

1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. ( 1.2 ) 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. 1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.

indications and usage tables exact

is original packager

true

manufacturer names

AstraZeneca Pharmaceuticals LP

matched search terms

cancer

package ndcs

0310-9500-01
0310-9500-02
0310-9501-01
0310-9501-95
0310-9501-02
0310-9501-96
0310-9501-04

product ndcs

0310-9500
0310-9501

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.2 ) 06/2026 Dosage and Administration ( 2.1 , 2.3 ) 06/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 06/2026

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2669972
2669978
2669980
2669982

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

NDA218197

brand names

TRUQAP

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

context span

end: 335
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic bre
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 0

current approval status

not_reconciled

duplicate text group

dup-91a2620d3fc71789660c

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-6a3cc6d5597f52642648

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

end: 62
end exclusive: true
exact text: is a kinase inhibitor indicated
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 31

qualifier mentions

context exact
USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer
kind
biomarker
polarity
not_inferred
span
end
121
end exclusive
true
exact text
HER2 negative locally advanced or metastatic
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
77
context exact
is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer
kind
stage_or_setting
polarity
not_inferred
span
end
135
end exclusive
true
exact text
locally advanced or metastatic breast cancer
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
91

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 135
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 2 · positive indication candidate

application numbers

NDA218197

brand names

TRUQAP

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 787
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with m
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 0

current approval status

not_reconciled

duplicate text group

dup-e062133c02ac4fb15e67

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-7fb98548bcc01836d158

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

end: 62
end exclusive: true
exact text: is a kinase inhibitor indicated
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 31

qualifier mentions

context exact
• in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth
kind
age
polarity
not_inferred
span
end
205
end exclusive
true
exact text
adult patients
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
191
context exact
or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or m
kind
biomarker
polarity
not_inferred
span
end
299
end exclusive
true
exact text
HER2)-negative
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
285
context exact
owth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorize
kind
biomarker
polarity
not_inferred
span
end
364
end exclusive
true
exact text
metastatic breast cancer with one or more P
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
321
context exact
dvanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endoc
kind
biomarker
polarity
not_inferred
span
end
414
end exclusive
true
exact text
AKT1/PTEN -alterations as detected by an FDA
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
370
context exact
progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
kind
biomarker
polarity
not_inferred
span
end
543
end exclusive
true
exact text
metastatic setting or recurrence on or with
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
500
context exact
, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an F
kind
stage_or_setting
polarity
not_inferred
span
end
352
end exclusive
true
exact text
locally advanced or metastatic breast cancer with o
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
301
context exact
progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
545
end exclusive
true
exact text
metastatic setting or recurrence on or within
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
500
context exact
setting or recurrence on or within 12 months of completing adjuvant therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
586
end exclusive
true
exact text
adjuvant therapy
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
570
context exact
• in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PT
kind
regimen
polarity
not_inferred
span
end
317
end exclusive
true
exact text
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
138

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 587
end exclusive: true
exact text: • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 136

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 3 · unclassified context

application numbers

NDA218197

brand names

TRUQAP

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 895
end exclusive: true
exact text: ions as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient a
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 388

current approval status

not_reconciled

duplicate text group

dup-8dddd41715d8bd6bcecf

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-93e2f88009ef4bdf6fa5

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

Source null

qualifier mentions

context exact
( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer
kind
biomarker
polarity
not_inferred
span
end
640
end exclusive
true
exact text
PTEN-deficient metastatic androgen pathway m
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
596
context exact
( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer
kind
stage_or_setting
polarity
not_inferred
span
end
656
end exclusive
true
exact text
metastatic androgen pathway modulation-naïve
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
611

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 695
end exclusive: true
exact text: ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 588

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · positive indication candidate

application numbers

NDA218197

brand names

TRUQAP

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1132
end exclusive: true
exact text: the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. ( 1.1 ) PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. ( 1.2 ) 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 496

current approval status

not_reconciled

duplicate text group

dup-e9beed8320c2d573176e

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-ae5ef926488516e8e316

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

end: 62
end exclusive: true
exact text: is a kinase inhibitor indicated
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 31

qualifier mentions

context exact
nation with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensi
kind
age
polarity
not_inferred
span
end
780
end exclusive
true
exact text
adult patients
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
766
context exact
one and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-defic
kind
biomarker
polarity
not_inferred
span
end
829
end exclusive
true
exact text
metastatic androgen pathway modulation-naïv
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
786
context exact
ation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
kind
biomarker
polarity
not_inferred
span
end
923
end exclusive
true
exact text
PTEN-deficient as detected by an FDA-authori
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
879
context exact
one and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficie
kind
stage_or_setting
polarity
not_inferred
span
end
831
end exclusive
true
exact text
metastatic androgen pathway modulation-naïve
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
786
context exact
• in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
kind
regimen
polarity
not_inferred
span
end
877
end exclusive
true
exact text
in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that i
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
698

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 932
end exclusive: true
exact text: • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 696

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 5 · unclassified context

application numbers

NDA218197

brand names

TRUQAP

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1140
end exclusive: true
exact text: prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. ( 1.2 ) 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positi
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 733

current approval status

not_reconciled

duplicate text group

dup-e5723a0b53421937c246

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-cd22c51a47836bff6aab

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 940
end exclusive: true
exact text: ( 1.2 )
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 933

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 6 · positive indication candidate

application numbers

NDA218197

brand names

TRUQAP

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1687
end exclusive: true
exact text: one for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. ( 1.2 ) 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. 1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with abiraterone and prednisone, is indicated for treatment of adult patients with
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 741

current approval status

not_reconciled

duplicate text group

dup-e6c3ba44c5650fcf9f79

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-140ab37a90bfde4e0091

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

end: 1070
end exclusive: true
exact text: is indicated
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 1058

qualifier mentions

context exact
ination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth
kind
age
polarity
not_inferred
span
end
1106
end exclusive
true
exact text
adult patients
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1092
context exact
1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is i
kind
biomarker
polarity
not_inferred
span
end
1002
end exclusive
true
exact text
HER2-negative locally advanced or metastatic
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
958
context exact
or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or m
kind
biomarker
polarity
not_inferred
span
end
1200
end exclusive
true
exact text
HER2)-negative
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1186
context exact
owth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-authorized
kind
biomarker
polarity
not_inferred
span
end
1265
end exclusive
true
exact text
metastatic breast cancer with one or more P
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1222
context exact
dvanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-authorized test following progression on at least one endocr
kind
biomarker
polarity
not_inferred
span
end
1315
end exclusive
true
exact text
AKT1/PTEN -alteration as detected by an FDA-
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1271
context exact
progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
kind
biomarker
polarity
not_inferred
span
end
1443
end exclusive
true
exact text
metastatic setting or recurrence on or with
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1400
context exact
1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the trea
kind
stage_or_setting
polarity
not_inferred
span
end
1023
end exclusive
true
exact text
locally advanced or metastatic breast cancer TRUQAP
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
972
context exact
, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FD
kind
stage_or_setting
polarity
not_inferred
span
end
1253
end exclusive
true
exact text
locally advanced or metastatic breast cancer with o
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1202
context exact
progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1445
end exclusive
true
exact text
metastatic setting or recurrence on or within
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1400
context exact
setting or recurrence on or within 12 months of completing adjuvant therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1486
end exclusive
true
exact text
adjuvant therapy
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1470
context exact
gative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more
kind
regimen
polarity
not_inferred
span
end
1204
end exclusive
true
exact text
in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lo
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1025

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1487
end exclusive: true
exact text: 1.1 HR-positive, HER2-negative locally advanced or metastatic breast cancer TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 941

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 7 · positive indication candidate

application numbers

NDA218197

brand names

TRUQAP

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1834
end exclusive: true
exact text: tion as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. 1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 1288

current approval status

not_reconciled

duplicate text group

dup-38da0b79ef668dbb8e7f

extraction review status

automated_candidate_pending_source_review

generic names

CAPIVASERTIB

ind-span-988cf44dcd2878aef716

label id

d2081b19-6f23-454d-b426-2710d8319f23

positive predicate support span

end: 1650
end exclusive: true
exact text: is indicated
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 1638

qualifier mentions

context exact
h abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensi
kind
age
polarity
not_inferred
span
end
1682
end exclusive
true
exact text
adult patients
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1668
context exact
1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in com
kind
biomarker
polarity
not_inferred
span
end
1536
end exclusive
true
exact text
PTEN-deficient metastatic androgen pathway m
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1492
context exact
ednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-defic
kind
biomarker
polarity
not_inferred
span
end
1731
end exclusive
true
exact text
metastatic androgen pathway modulation-naïv
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1688
context exact
ation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
kind
biomarker
polarity
not_inferred
span
end
1825
end exclusive
true
exact text
PTEN-deficient as detected by an FDA-authori
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1781
context exact
1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with ab
kind
stage_or_setting
polarity
not_inferred
span
end
1552
end exclusive
true
exact text
metastatic androgen pathway modulation-naïve
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1507
context exact
ednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficie
kind
stage_or_setting
polarity
not_inferred
span
end
1733
end exclusive
true
exact text
metastatic androgen pathway modulation-naïve
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1688
context exact
hway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized
kind
regimen
polarity
not_inferred
span
end
1769
end exclusive
true
exact text
in combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate can
label id
d2081b19-6f23-454d-b426-2710d8319f23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start
1590

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1834
end exclusive: true
exact text: 1.2 PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer TRUQAP, in combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
label id: d2081b19-6f23-454d-b426-2710d8319f23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 9b6d4d4fe705354ecde722ec3a88c47f3b4cb1a20539fa6d78fe9c4ce1110d96
start: 1488

source url

https://api.fda.gov/drug/label.json?search=id%3A%22d2081b19-6f23-454d-b426-2710d8319f23%22

spl effective date

2026-06-12

spl set id

d698c106-2322-401e-b738-cbd83c843ecf

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Preserved source evidence · Not medical advice